Canned fruit juices (21 CFR 146.3-146.187)

593 Food and Drug Administration, HHS Pt. 146 ‘‘heavily sweetened fruit juice(s)’’, as the case may be. (iv) When the density of the solution is 30 percent or more but not more than 45 percent, the medium shall be designated as ‘‘extra heavy sirup’’; ‘‘extra heavily sweetened fruit juice(s) and water’’; or ‘‘extra heavily sweet ened fruit juice(s)’’, as the case may be. (c) Labeling requirements. (1) The name of the food is ‘‘prunes—prepared from dried prunes’’. The words ‘‘pre pared from dried prunes’’ shall be in close proximity to the word ‘‘prunes’’ and shall be of the same style and not less than 1⁄2 of the point size of the type used for the word ‘‘prunes’’. The name of the food shall also include a declara tion of any flavoring that characterizes the product as specified in § 101.22 of this chapter and a declaration of any spice or seasoning that characterizes the product; for example, ‘‘Spice added’’, or in lieu of the word ‘‘Spice’’, the common name of the spice, ‘‘Sea soned with vinegar’’ or ‘‘Seasoned with unpeeled pieces of citrus fruit’’. When two or more of the optional ingredients specified in paragraphs (a) (2) through (4) of this section are used, such words may be combined as for example, ‘‘Seasoned with cider vinegar, cloves, cinnamon oil and unpeeled pieces of citrus fruit.’’ (2) When the food is prepared with a packing medium, the name of the packing medium specified in para graphs (b) (1) and (2) of this section, preceded by ‘‘In’’ or ‘‘Packed in’’ and the words ‘‘cooked’’, ‘‘stewed’’, or ‘‘prepared’’, shall be included as part of the name or in close proximity to the name of the food. When no packing me dium is used, the words ‘‘solid pack’’ or ‘‘moist pack’’ or the word ‘‘moistened’’ followed by the words ‘‘without sirup’’ shall be included as part of the name or in close proximity to the name of the food. When the packing medium is pre pared with a sweetener(s) which im parts a taste, flavor or other char acteristic to the finished food in addi tion to sweetness, the name of the packing medium shall be accompanied by the name of such sweetener(s), as for example in the case of a mixture of brown sugar and honey, an appropriate statement would be ‘‘lll sirup of brown sugar and honey’’, the blank to be filled in with the word ‘‘light’’, ‘‘heavy’’, or ‘‘extra heavy’’ as the case may be. When the liquid portion of the packing media provided for in para graphs (b) (1) and (2) of this section consists of fruit juice(s), such juice(s) shall be designated in the name of the packing medium as: (i) In the case of a single fruit juice, the name of the juice shall be used in lieu of the word ‘‘fruit’’, (ii) In the case of a combination of two or more fruit juices, the names of the juices in the order of predominance by weight shall either be used in lieu of the word ‘‘fruit’’ in the name of the packing medium, or be declared on the label as specified in paragraph (c)(3) of this section, and (iii) In the case of the single fruit juice or a combination of two or more fruit juices any of which are made from concentrate(s), the words ‘‘from con centrate(s)’’ shall follow the word ‘‘juice(s)’’ in the name of the packing medium and in the name(s) of such juice(s) when declared as specified in paragraph (c)(3) of this section. (3) Whenever the names of the fruit juices used do not appear in the name of the packing medium as provided in paragraph (c)(2)(ii) of this section, such names and the words ‘‘from con centrate’’, as specified in paragraph (c)(2)(iii) of this section, shall appear in an ingredient statement pursuant to the requirements of § 101.3(d) of this chapter. (4) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14414, Mar. 15, 1977, as amended at 58 FR 2880, Jan. 6, 1993] PART 146—CANNED FRUIT JUICES Subpart A—General Provisions Sec. 146.3 Definitions. Subpart B—Requirements for Specific Standardized Canned Fruit Juices and Beverages 146.114 Lemon juice. 146.120 Frozen concentrate for lemonade. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00603 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 594 21 CFR Ch. I (4–1–16 Edition) § 146.3 146.121 Frozen concentrate for artificially sweetened lemonade. 146.126 Frozen concentrate for colored lem onade. 146.132 Grapefruit juice. 146.135 Orange juice. 146.137 Frozen orange juice. 146.140 Pasteurized orange juice. 146.141 Canned orange juice. 146.145 Orange juice from concentrate. 146.146 Frozen concentrated orange juice. 146.148 Reduced acid frozen concentrated or ange juice. 146.150 Canned concentrated orange juice. 146.151 Orange juice for manufacturing. 146.152 Orange juice with preservative. 146.153 Concentrated orange juice for manu facturing. 146.154 Concentrated orange juice with pre servative. 146.185 Pineapple juice. 146.187 Canned prune juice. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14433, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 146.3 Definitions. For the purposes of this part: (a) The term corn sirup means a clari fied, concentrated, aqueous solution of the products obtained by the incom plete hydrolysis of cornstarch, and in cludes dried corn sirup. The solids of corn sirup and of dried corn sirup con tain not less than 40 percent by weight of reducing sugars calculated as anhy drous dextrose. (b) The term dextrose means the hy drated or anhydrous, refined monosaccharide obtained from hydrolyzed starch. (c) The term dried glucose sirup means the product obtained by drying glucose sirup. (d) The term glucose sirup means a clarified, concentrated, aqueous solu tion of the products obtained by the in complete hydrolysis of any edible starch. The solids of glucose sirup con tain not less than 40 percent by weight of reducing sugars calculated as anhy drous dextrose. (e) The term invert sugar sirup means an aqueous solution of inverted or partly inverted, refined or partly re fined sucrose, the solids of which con tain not more than 0.3 percent by weight of ash, and which is colorless, odorless, and flavorless, except for sweetness. (f) The term sugar means refined su crose. (g) Compliance means the following: Unless otherwise provided in a stand ard, a lot of canned fruits shall be deemed in compliance for the following factors, to be determined by the sam pling and acceptance procedure as pro vided in paragraph (h) of this section, namely: (1) Quality. The quality of a lot shall be considered acceptable when the number of defectives does not exceed the acceptance number in the sampling plans. (2) Fill of container. A lot shall be deemed to be in compliance for fill of container when the number of defectives does not exceed the accept ance number (c) in the sampling plans. (h) The sampling and acceptance pro cedure means the following: (1) Definitions—(i) Lot. A collection of primary containers or units of the same size, type, and style manufac tured or packed under similar condi tions and handled as a single unit of trade. (ii) Lot size. The number of primary containers or units in the lot. (iii) Sample size. The total number of sample units drawn for examination from a lot. (iv) Sample unit. A container, a por tion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit. (v) Defective. Any sample unit shall be regarded as defective when the sam ple unit does not meet the criteria set forth in the standards. (vi) Acceptance number (c). The max imum number of defective sample units permitted in the sample in order to consider the lot as meeting the speci fied requirements. (vii) Acceptable quality level (AQL). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 per cent of the time. (2) Sampling plans: VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00604 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 595 Food and Drug Administration, HHS § 146.114 Lot size (primary containers) Size of container n 1 c 2 NET WEIGHT EQUAL TO OR LESS THAN 1 KG (2.2 LB) 4,800 or less ...................................... 13 2 4,801 to 24,000 ................................. 21 3 24,001 to 48,000 ............................... 29 4 48,001 to 84,000 ............................... 48 6 84,001 to 144,000 ............................. 84 9 144,001 to 240,000 ........................... 126 13 Over 240,000 ..................................... 200 19 NET WEIGHT GREATER THAN 1 KG (2.2 LB) BUT NOT MORE THAN 4.5 KG (10 LB) 2,400 or less ...................................... 13 2 2,401 to 15,000 ................................. 21 3 15,001 to 24,000 ............................... 29 4 24,001 to 42,000 ............................... 48 6 42,001 to 72,000 ............................... 84 9 72,001 to 120,000 ............................. 126 13 Over 120,000 ..................................... 200 19 NET WEIGHT GREATER THAN 4.5 KG (10 LB) 600 or less ......................................... 13 2 601 to 2,000 ...................................... 21 3 2,001 to 7,200 ................................... 29 4 7,201 to 15,000 ................................. 48 6 15,001 to 24,000 ............................... 84 9 24,001 to 42,000 ............................... 126 13 Over 42,000 ....................................... 200 19 1 n = number of primary containers in sample. 2 c = acceptance number. Subpart B—Requirements for Spe cific Standardized Canned Fruit Juices and Beverages § 146.114 Lemon juice. (a) Identity—(1) Description. Lemon juice is the unfermented juice, ob tained by mechanical process, from sound, mature lemons (Citrus limon (L.) Burm. f.), from which seeds (except em bryonic seeds and small fragments of seed which cannot be separated by good manufacturing practice) and excess pulp are removed. The juice may be ad justed by the addition of the optional concentrated lemon juice ingredient specified in paragraph (a)(2) of this sec tion in such quantity so that the in crease in acidity, calculated as anhy drous citric acid, does not exceed 15 percent of the acidity of the finished food. The lemon oil and lemon essence (derived from lemons) content may be adjusted in accordance with good man ufacturing practice. The juice may have been concentrated and later re constituted. When prepared from con centrated lemon juice, the finished food contains not less than 6 percent, by weight, of soluble solids taken as the refractometric sucrose value (of the filtrate), corrected to 20 °C, but un corrected for acidity, in accordance with the ‘‘International Scale of Re fractive Indices of Sucrose Solutions’’ in section 52.012 of ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by reference, and has a titratable acidity content of not less than 4.5 percent, by weight, cal culated as anhydrous citrus acid. Cop ies of the incorporation by reference may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. The food may con tain one or any combination of the safe and suitable optional ingredients speci fied in paragraph (a)(2) of this section. Lemon juice, as defined in this para graph, may be preserved by heat steri lization (canning), refrigeration, freez ing, or by the addition of safe and suit able preservatives. When sealed in a container to be held at ambient tem peratures, it is preserved by the addi tion of safe and suitable preservatives or so processed by heat, before or after sealing, as to prevent spoilage. (2) Optional ingredients. The optional safe and suitable ingredients referred to in paragraph (a)(1) of this section are: (i) Concentrated lemon juice (lemon juice from which part of the water has been removed). (ii) Water and/or lemon juice to re constitute concentrated lemon juice in the manufacture of lemon juice from concentrate. (iii) Preservatives. (3) Labeling. (i) The name of the food is: (a) ‘‘Lemon juice’’ (1) if the food is prepared from unconcentrated, undi luted liquid extracted from mature lemons; or (2) if the food is prepared from unconcentrated, undiluted liquid extracted from mature lemons to which concentrated lemon juice is VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00605 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 596 21 CFR Ch. I (4–1–16 Edition) § 146.120 added to adjust acidity as provided for in paragraph (a)(1) of this section. (b) ‘‘Lemon juice from concentrate’’ or ‘‘reconstituted lemon juice’’ (1) if the food is prepared from concentrated lemon juice and water and/or lemon juice; or (2) if the food is prepared from lemon juice from concentrate and lemon juice. The words ‘‘from con centrate’’ or ‘‘reconstituted’’ shall be shown in letters not less than one-half the height of the letters in the word ‘‘lemon juice.’’ (ii) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (b) [Reserved] (c) Fill of container. (1) The standard of fill of container for lemon juice, ex cept when the food is frozen, is not less than 90 percent of the total capacity of the container as determined by the general method for fill of container prescribed in § 130.12(b) of this chapter, except (i) When the food is frozen or (ii) When the food is packaged in in dividual serving-size packages, con taining 1⁄2 fluid ounce or less, for use as described in § 1.24(a)(3) of this chapter. (2) Compliance is determined as spec ified in § 146.3(g)(2). (3) If the lemon juice fails to meet the standard of fill as prescribed in paragraph (c) (1) and (2) of this section, the label shall bear the general state ment of substandard fill specified in § 130.14(b) of this chapter, in the man ner and form therein prescribed. [45 FR 7786, Feb. 5, 1980, as amended at 47 FR 11830, Mar. 19, 1982; 49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2881, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 146.120 Frozen concentrate for lem onade. (a) Frozen concentrate for lemonade is the frozen food prepared from one or both of the lemon juice ingredients specified in paragraph (b) of this sec tion together with one or any mixture of safe and suitable nutritive carbo hydrate sweeteners. The product con tains not less than 48.0 percent by weight of soluble solids taken as the sucrose value determined by refrac tometer and corrected for acidity pre scribed in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists,’’ 13th Ed. (1980), sec tion 22.025, ‘‘Frozen Concentrate for Lemonade (12),’’ under the heading ‘‘Soluble Solids by Refractometer—Of ficial First Action,’’ which is incor porated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html When the product is diluted according to directions for making lemonade which shall appear on the label, the acidity of the lem onade, calculated as anhydrous citric acid, shall be not less than 0.70 gram per 100 milliliters, and the soluble sol ids, measured as described for the con centrate, shall be not less than 10.5 per cent by weight. (b) The lemon juice ingredients re ferred to in paragraph (a) of this sec tion are: (1) Lemon juice or frozen lemon juice or a mixture of these. (2) Concentrated lemon juice or fro zen concentrated lemon juice or a mix ture of these. For the purposes of this section, lemon juice is the undiluted juice expressed from mature lemons of an acid variety; and concentrated lemon juice is lemon juice from which part of the water has been removed. In the preparation of the lemon juice ingredients, the lemon oil content may be adjusted by the addi tion of lemon oil or concentrated lemon oil in accordance with good manufacturing practice, and the lemon pulp in the juice as expressed may be left in the juice or may be separated. Lemon pulp that has been separated, which may have been preserved by freezing, may be added in preparing frozen concentrate for lemonade, pro vided that the amount of pulp added does not raise the proportion of pulp in the finished food to a level in excess of that which would be present by using lemon juice ingredients from which pulp has not been separated. The lemon VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00606 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 597 Food and Drug Administration, HHS § 146.132 juice ingredients may be treated by heat, either before or after the other ingredients are added, to reduce the en zymatic activity and the number of viable microorganisms. (c) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19, 1982; 49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2881, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 146.121 Frozen concentrate for artifi cially sweetened lemonade. (a) Frozen concentrate for artifi cially sweetened lemonade conforms to the definition and standard of identity prescribed for frozen concentrate for lemonade by § 146.120, except that in lieu of nutritive sweeteners it is sweet ened with one or more of the artificial sweetening ingredients listed in and complying with the requirements of parts 172, 180 or 184 of this chapter, and the soluble solids specifications pre scribed in § 146.120(a) do not apply. When the product is diluted according to directions which shall appear on the label, the acidity of the artificially sweetened lemonade, calculated as an hydrous citric acid, shall be not less than 0.70 gram per 100 milliliters. It may contain one or more safe and suit able dispersing ingredients serving the function of distributing the lemon oil throughout the food. It may also con tain one or more safe and suitable thickening ingredients. Such dis persing and thickening ingredients are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or if they are food addi tives as so defined, they are used in conformity with regulations estab lished pursuant to section 409 of the act. (b) [Reserved] (c) The name of the food is ‘‘Frozen concentrate for artificially sweetened lemonade’’. The words ‘‘artificially sweetened’’ shall be of the same size and style of type as the word ‘‘lem onade’’. (d) If an optional thickening or dis persing ingredient referred to in para graph (a) of this section is used, the label shall bear the statement ‘‘lll added’’ or ‘‘with added lll’’, the blank being filled in with the common name of the thickening or dispersing agent used. Such statement shall be set forth on the label with such promi nence and conspicuousness as to render it likely to be read and understood by the ordinary individual under cus tomary conditions of purchase. (e) Frozen concentrate for artificially sweetened lemonade is labeled to con form to the labeling requirements pre scribed for foods which purport to be or are represented for special dietary use by regulations promulgated pursuant to section 403(j) of the act. (f) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993] § 146.126 Frozen concentrate for col ored lemonade. (a) Frozen concentrate for colored lemonade conforms to the definition and standard of identity prescribed for frozen concentrate for lemonade by § 146.120, except that it is colored with a safe and suitable fruit juice, vegetable juice, or any such juice in concentrated form, or with any other color additive ingredient suitable for use in food, in cluding artificial coloring, used in con formity with regulations established pursuant to section 721 of the Federal Food, Drug, and Cosmetic Act. (b) The name of the food is ‘‘Frozen concentrate for lll lemonade’’, the blank being filled in with the word de scribing the color: for example, ‘‘Fro zen concentrate for pink lemonade’’. (c) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993] § 146.132 Grapefruit juice. (a) Identity—(1) Description. Grape fruit juice is the unfermented juice, in tended for direct consumption, ob tained by mechanical process from VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00607 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 598 21 CFR Ch. I (4–1–16 Edition) § 146.132 sound, mature grapefruit (Citrus paradisi Macfadyen) from which seeds and peel (except embryonic seeds and small fragments of seeds and peel which cannot be separated by good manufacturing practice) and excess pulp are removed and to which may be added not more than 10 percent by vol ume of the unfermented juice obtained from mature hybrids of grapefruit. The juice may be adjusted by the addition of the optional concentrated grapefruit juice ingredients specified in paragraph (a)(2) of this section, but the quantity of such concentrated grapefruit juice ingredient added shall not contribute more than 15 percent of the grapefruit juice soluble solids in the finished food. The grapefruit pulp, grapefruit oil, and grapefuit essence (components derived from grapefruit) content may be ad justed in accordance with good manu facturing practice. The juice may have been concentrated and later reconsti tuted with water suitable for the pur pose of maintaining essential composi tion and quality factors of the juice. It may be sweetened with the dry nutri tive sweeteners referred to in para graph (a)(2)(iii) of this section. If the grapefruit juice is prepared from con centrate, such sweeteners, in liquid form, referred to in paragraph (a)(2)(iii) of this section, also may be used. When prepared from concentrated grapefruit juice, exclusive of added sweeteners, the finished food contains not less than 10 percent, by weight, of soluble solids taken as the refractometric sucrose value (of the filtrate), corrected to 20 °C, and corrected for acidity by adding (0.012 + 0.193x–0.0004x2), where x equals the percent anhydrous citric acid in the sample, to the refractometrically obtained sucrose value by the first method prescribed in ‘‘Correction of Refractometer Sucrose Readings for Citric Acid Content for Lemonade,’’ by Yeatman, Senzel, and Springer, ‘‘Jour nal of the Association of Official Ana lytical Chemists,’’ vol. 59 p. 368 (1976). Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the Na tional Archives and Records Adminis tration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. The food may con tain one or any combination of the op tional ingredients specified in para graph (a)(2) of this section. Grapefruit juice, as defined in this paragraph, may be preserved by heat sterlization (can ning), refrigeration, or freezing. When sealed in a container to be held at am bient temperatures, it is so processed by heat, before or after sealing, as to prevent spoilage. (2) Optional ingredients. The optional ingredients referred to in paragraph (a)(1) of this section are: (i) Concentrated grapefruit juice (grapefruit juice from which part of the water has been removed). (ii) Water and/or grapefruit juice to reconstitute concentrated grapefruit juice in the manufacture of grapefruit juice from concentrate. (iii) One or any combination of two or more of the dry or liquid forms of sugar, invert sugar sirup, dextrose, glu cose sirup, and fructose. Sweeteners de fined in part 168 of this chapter shall be as defined therein. (3) Labeling. (i) The name of the food is: (a) ‘‘Grapefruit juice’’ (1) if the food is prepared from unconcentrated, undi luted liquid extracted from mature grapefruit; or (2) if the food is prepared from unconcentrated, undiluted liquid extracted from mature grapefruit to which concentrated grapefruit juice is added to adjust soluble solids as pro vided for in paragraph (a)(1) of this sec tion. (b) ‘‘Grapefruit juice from con centrate’’ (1) if the food is prepared from concentrated grapefruit juice and water and/or grapefruit juice; or (2) if the food is prepared from grapefuit juice from concentrate and grapefruit juice. The words ‘‘from concentrate’’ shall be shown in letters not less than one-half the height of the letters in the words ‘‘grapefruit juice.’’ (ii) If any nutritive sweetener is added, the principal display panel of the label shall bear the statement ‘‘Sweetener added.’’ If no sweetener is added, the word ‘‘unsweetened’’ may immediately precede or follow the words ‘‘Grapefruit Juice’’ or ‘‘Grape fruit Juice from Concentrate.’’ VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00608 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 599 Food and Drug Administration, HHS § 146.140 (iii) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (b) [Reserved] (c) Fill of container. (1) The standard of fill of container for grapefruit juice, except when the food is frozen, is not less than 90 percent of the total capac ity of the container as determined by the general method for fill of container prescribed in § 130.12(b) of this chapter. (2) Compliance is determined as spec ified in § 146.3(g)(2). (3) If the grapefruit juice fails to meet the standard of fill as prescribed in paragraphs (c) (1) and (2) of this sec tion, the label shall bear the general statement of substandard fill specified in § 130.14(b) of this chapter, in the manner and form therein prescribed. [46 FR 8464, Jan. 27, 1981; 46 FR 21359, Apr. 10, 1981; 46 FR 26300, May 12, 1981, as amended at 47 FR 11830, Mar. 19, 1982; 47 FR 24287, June 4, 1982; 47 FR 43364, Oct. 1, 1982; 58 FR 2881, Jan. 6, 1993; 66 FR 17359, Mar. 30, 2001] § 146.135 Orange juice. (a) Orange juice is the unfermented juice obtained from mature oranges of the species Citrus sinensis or of the cit rus hybrid commonly called ‘‘Ambersweet’’ (1⁄2 Citrus sinensis X 3⁄8 Citrus reticulata X 1⁄8 Citrus paradisi (USDA Selection:1–100–29: 1972 Whitmore Foundation Farm)). Seeds (except embryonic seeds and small fragments of seeds that cannot be sepa rated by current good manufacturing practice) and excess pulp are removed. The juice may be chilled, but it is not frozen. (b) The name of the food is ‘‘orange juice’’. The name ‘‘orange juice’’ may be preceded on the label by the varietal name of the oranges used, and if the or anges grew in a single State, the name of such State may be included in the name, as for example, ‘‘California Va lencia orange juice’’. [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992] § 146.137 Frozen orange juice. (a) Frozen orange juice is orange juice as defined in § 146.135, except that it is frozen. (b) The name of the food is ‘‘Frozen orange juice’’. Such name may be pre ceded on the label by the varietal name of the oranges used, and if the oranges grew in a single State, the name of such State may be included in the name, as for example, ‘‘California Va lencia frozen orange juice’’. § 146.140 Pasteurized orange juice. (a) Pasteurized orange juice is the food prepared from unfermented juice obtained from mature oranges as speci fied in § 146.135, to which may be added not more that 10 percent by volume of the unfermented juice obtained from mature oranges of the species Citrus reticulata or Citrus reticulata hybrids (except that this limitation shall not apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufac turing practice) are removed, and pulp and orange oil may be adjusted in ac cordance with good manufacturing practice. If the adjustment involves the addition of pulp, then such pulp shall not be of the washed or spent type. The solids may be adjusted by the addition of one or more of the optional con centrated orange juice ingredients specified in paragraph (b) of this sec tion. One or more of the optional sweetening ingredients listed in para graph (c) of this section may be added in a quantity reasonably necessary to raise the Brix or the Brix-acid ratio to any point within the normal range usu ally found in unfermented juice ob tained from mature oranges as speci fied in § 146.135. The orange juice is so treated by heat as to reduce substan tially the enzymatic activity and the number of viable microorganisms. Ei ther before or after such heat treat ment, all or a part of the product may be frozen. The finished pasteurized or ange juice contains not less than 10.5 percent by weight of orange juice solu ble solids, exclusive of the solids of any added optional sweetening ingredients, and the ratio of the Brix hydrometer reading to the grams of anhydrous cit ric acid per 100 milliliters of juice is not less than 10 to 1. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00609 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 600 21 CFR Ch. I (4–1–16 Edition) § 146.141 (b) The optional concentrated orange juice ingredients referred to in para graph (a) of this section are frozen con centrated orange juice as specified in § 146.146 and concentrated orange juice for manufacturing as specified in § 146.153 when made from mature or anges; but the quantity of such con centrated orange juice ingredients added shall not contribute more than one-fourth of the total orange juice sol ids in the finished pasteurized orange juice. (c) The optional sweetening ingredi ents referred to in paragraph (a) of this section are sugar, invert sugar, dex trose, dried corn sirup, dried glucose sirup. (d)(1) The name of the food is ‘‘Pas teurized orange juice’’. If the food is filled into containers and preserved by freezing, the label shall bear the name ‘‘Frozen pasteurized orange juice’’. The words ‘‘pasteurized’’ or ‘‘frozen pas teurized’’ shall be shown on labels in letters not less than one-half the height of the letters in the words ‘‘or ange juice’’. (2) If the pasteurized orange juice is filled into containers and refrigerated, the label shall bear the name of the food, ‘‘chilled pasteurized orange juice’’. If it does not purport to be ei ther canned orange juice or frozen pas teurized orange juice, the word ‘‘chilled’’ may be omitted from the name. The words ‘‘pasteurized’’ or ‘‘chilled pasteurized’’ shall be shown in letters not less than one-half the height of the letters in the words ‘‘or ange juice’’. (e)(1) If a concentrated orange juice ingredient specified in paragraph (b) of this section is used in adjusting the or ange juice solids of the pasteurized or ange juice, the label shall bear the statement ‘‘prepared in part from con centrated orange juice’’ or ‘‘with added concentrated orange juice’’ or ‘‘con centrated orange juice added’’. (2) If one or more of the sweetening ingredients specified in paragraph (c) of this section are added to the pas teurized orange juice, the label shall bear the statement ‘‘lll added’’, the blank being filled in with the name or an appropriate combination of the names of the sweetening ingredients used. However, for the purpose of this section, the name ‘‘sweetener’’ may be used in lieu of the specific name or names of the sweetening ingredients. (f) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statements specified in this section for naming the optional ingredients used shall imme diately and conspicuously precede or follow the name of the food, without intervening written, printed, or graph ic matter. (g) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 FR 2881, Jan. 6, 1993] § 146.141 Canned orange juice. (a) Canned orange juice is the food prepared from orange juice as specified in § 146.135 or frozen orange juice as specified in § 146.137, or a combination of both, to which may be added not more than 10 percent by volume of the unfermented juice obtained from ma ture oranges of the species Citrus reticulata or Citrus reticulata hybrids (except that this limitation shall not apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufac turing practice) are removed. Orange oil and pulp may be adjusted in accord ance with good manufacturing prac tice. The adjustment of pulp referred to in this paragraph does not permit the addition of washed or spent pulp. Liq uid condensate recovered from the deoiling operation may be added back. One or more of the optional sweetening ingredients named in paragraph (b) of this section may be added, in a quan tity reasonably necessary to raise the Brix or the Brix-acid ratio to any point within the normal range usually found in unfermented juice obtained from mature oranges as specified in § 146.135. The food is sealed in containers and so processed by heat, either before or after sealing, as to prevent spoilage. The finished canned orange juice tests not less than 10° Brix, and the ratio of the Brix hydrometer reading to the grams of anhydrous citric acid per 100 VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00610 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 601 Food and Drug Administration, HHS § 146.145 milliliters of juice is not less than 9 to 1. (b) The optional sweetening ingredi ents referred to in paragraph (a) of this section are sugar, invert sugar, dex trose, dried corn sirup, dried glucose sirup. (c) The name of the food is ‘‘Canned orange juice’’. All the words in the name shall appear in the same size, color, and style of type and on the same color-contrasting background. If the food is not sold under refrigeration and if it does not purport to be chilled pasteurized orange juice or frozen pas teurized orange juice, the word ‘‘canned’’ may be omitted from the name. (d) If one or more of the sweetening ingredients specified in paragraph (b) of this section are added to the canned orange juice, the label shall bear the statement ‘‘lll added’’, the blank being filled in with the name or an ap propriate combination of the names of the sweetening ingredients used. How ever, for the purpose of this section, the name ‘‘sweetener’’ may be used in lieu of the specific name or names of the sweetening ingredients. (e) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statement specified in this section for naming the optional ingredients used shall imme diately and conspicuously precede or follow the name of the food, without intervening written, printed, or graph ic matter. (f) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 FR 2881, Jan. 6, 1993] § 146.145 Orange juice from con centrate. (a) Orange juice from concentrate is the food prepared by mixing water with frozen concentrated orange juice as de fined in § 146.146 or with concentrated orange juice for manufacturing as de fined in § 146.153 (when made from ma ture oranges), or both. To such mixture may be added orange juice as defined in § 146.135, frozen orange juice as defined in § 146.137, pasteurized orange juice as defined in § 146.140, orange juice for manufacturing as defined in § 146.151 (when made from mature oranges and preserved by chilling or freezing but not by canning), orange oil, orange pulp, and one or more of the sweet ening ingredients listed in paragraph (b) of this section. The finished orange juice from concentrate contains not less than 11.8 percent orange juice solu ble solids, exclusive of solids of any added optional sweetening ingredients. It may be so treated by heat as to re duce substantially the enzymatic ac tivity and the number of viable micro organisms. (b) The sweetening ingredients re ferred to in paragraph (a) of this sec tion are sugar, sugar sirup, invert sugar, invert sugar sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, dried glucose sirup. (c) The name of the food is ‘‘Orange juice from concentrate’’. The words ‘‘from concentrate’’ shall be shown in letters not less than one-half the height of the letters in the words ‘‘or ange juice’’. (d) When orange juice from con centrate contains any optional sweet ening ingredient as listed in paragraph (b) of this section, whether added di rectly as such or indirectly as an added ingredient of any orange juice product used, the label shall bear the statement ‘‘lll added’’, the blank being filled in with the name or an appropriate combination of the names of the sweet ening ingredients added. However, for the purposes of this section the name ‘‘sweetener’’ may be used in lieu of the specific name or names of the sweet ening ingredients. (e) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statements specified in this section for naming the optional ingredients used shall imme diately and conspicuously precede or follow the name of the food, without intervening written, printed, or graph ic matter. (f) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00611 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 602 21 CFR Ch. I (4–1–16 Edition) § 146.146 applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993] § 146.146 Frozen concentrated orange juice. (a) Frozen concentrated orange juice is the food prepared by removing water from the juice of mature oranges as provided in § 146.135, to which may be added unfermented juice obtained from mature oranges of the species Citrus reticulata, other Citrus reticulata hy brids, or of Citrus aurantium, or both. However, in the unconcentrated blend, the volume of juice from Citrus reticulata or Citrus reticulata hybrids shall not exceed 10 percent (except that this limitation shall not apply to the hybrid species described in § 146.135) and from Citrus aurantium shall not ex ceed 5 percent. The concentrate so ob tained is frozen. In its preparation, seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) and excess pulp are removed, and a properly prepared water extract of the excess pulp so removed may be added. Orange oil, orange pulp, orange essence (obtained from orange juice), orange juice and other orange juice concentrate as provided in this section or concentrated orange juice for manu facturing provided in § 146.153 (when made from mature oranges), water, and one or more of the optional sweetening ingredients specified in paragraph (b) of this section may be added to adjust the final composition. The juice of Cit rus reticulata and Citrus aurantium, as permitted by this paragraph, may be added in single strength or con centrated form prior to concentration of the Citrus sinensis juice, or in con centrated form during adjustment of the composition of the finished food. The addition of concentrated juice from Citrus reticulata or Citrus aurantium, or both, shall not exceed, on a single-strength basis, the 10 percent maximum for Citrus reticulata and the 5 percent maximum for Citrus aurantium prescribed by this paragraph. Any of the ingredients of the finished con centrate may have been so treated by heat as to reduce substantially the en zymatic activity and the number of viable microorganisms. The finished food is of such concentration that when diluted according to label directions the diluted article will contain not less than 11.8 percent by weight of orange juice soluble solids, exclusive of the solids of any added optional sweetening ingredients. The dilution ratio shall be not less than 3 plus 1. For the purposes of this section and § 146.150, the term ‘‘dilution ratio’’ means the whole num ber of volumes of water per volume of frozen concentrate required to produce orange juice from concentrate having orange juice soluble solids of not less than 11.8 percent by weight exclusive of the solids of any added optional sweet ening ingredients. (b) The optional sweetening ingredi ents referred to in paragraph (a) of this section are sugar, sugar sirup, invert sugar, invert sugar sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, and dried glucose sirup. (c) If one or more of the sweetening ingredients specified in paragraph (b) of this section are added to the frozen concentrated orange juice, the label shall bear the statement ‘‘lll added’’, the blank being filled in with the name or an appropriate combina tion of names of the sweetening ingre dients used. However, for the purpose of this section, the name ‘‘sweetener’’ may be used in lieu of the specific name or names of the sweetening in gredients. (d) The name of the food con centrated to a dilution ratio of 3 plus 1 is ‘‘frozen concentrated orange juice’’ or ‘‘frozen orange juice concentrate’’. The name of the food concentrated to a dilution ratio greater than 3 plus 1 is ‘‘frozen concentrated orange juice, lll plus 1’’ or ‘‘frozen orange juice concentrate, lll plus 1’’, the blank being filled in with the whole number showing the dilution ratio; for exam ple, ‘‘frozen orange juice concentrate, 4 plus 1’’. However, where the label bears directions for making 1 quart of orange juice from concentrate (or multiples of a quart), the blank in the name may be filled in with a mixed number; for ex ample, ‘‘frozen orange juice con centrate, 41⁄3 plus 1’’. For containers larger than 1 pint, the dilution ratio in VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00612 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 603 Food and Drug Administration, HHS § 146.151 the name may be replaced by the con centration of orange juice soluble sol ids in degrees Brix; for example, a 62° Brix concentrate in 31⁄2-gallon cans may be named on the label ‘‘frozen con centrated orange juice, 62° Brix’’. (e) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statements specified in this section for naming the optional ingredients used shall imme diately and conspicuously precede or follow the name of the food, without intervening written, printed, or graph ic matter. (f) Nothing in this section is intended to interfere with the adoption and en forcement by any State, in regulating the production of frozen concentrated orange juice in such State, of State standards, consistent with this section, but which impose higher or more re strictive requirements than those set forth in this section. (g) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992; 58 FR 2881, Jan. 6, 1993] § 146.148 Reduced acid frozen con centrated orange juice. (a) Reduced acid frozen concentrated orange juice is the food that complies with the requirements for composition and label declaration of ingredients prescribed for frozen concentrated or ange juice by § 146.146, except that it may not contain any added sweetening ingredient. A process involving the use of anionic ion-exchange resins per mitted by § 173.25 of this chapter is used to reduce the acidity of the food so that the ratio of the Brix reading to the grams of acid, expressed as anhy drous citric acid, per 100 grams of juice is not less than 21 to 1 or more than 26 to 1. (b) The name of the food is ‘‘Reduced acid frozen concentrated orange juice’’. [45 FR 12414, Feb. 26, 1980, as amended at 58 FR 2881, Jan. 6, 1993] § 146.150 Canned concentrated orange juice. (a) Canned concentrated orange juice is the food that complies with the re quirements of composition, definition of dilution ratio, and labeling of ingre dients prescribed for frozen con centrated orange juice by § 146.146, ex cept that it is not frozen and it is sealed in containers and so processed by heat, either before or after sealing, so as to prevent spoilage. (b) The name of the food when con centrated to a dilution ratio of 3 plus 1 is ‘‘Canned concentrated orange juice’’ or ‘‘Canned orange juice concentrate’’. The name of the food when con centrated to a dilution ratio greater than 3 plus 1 is ‘‘Canned concentrated orange juice, lll plus 1’’ or ‘‘Canned orange juice concentrate, lll plus 1’’, the blank being filled in with the whole number showing the dilution ratio; for example, ‘‘Canned orange juice concentrate, 4 plus 1’’. However, where the label bears directions for making 1 quart of single-strength di luted product (or multiples of a quart) the blank in the name may be filled in with a mixed number; for example, ‘‘Canned orange juice concentrate, 41⁄3 plus 1’’. For containers larger than 1 pint, the dilution ratio in the name may be replaced by the concentration of orange juice soluble solids in degrees Brix; for example, a 62° Brix con centrate in 1-gallon cans may be named on the label ‘‘canned concentrated or ange juice, 62° Brix’’. If the food does not purport to be frozen concentrated orange juice, the word ‘‘canned’’ may be omitted from the name. [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993] § 146.151 Orange juice for manufac turing. (a) Orange juice for manufacturing is the food prepared for further manufac turing use. It is prepared from unfermented juice obtained from or anges as provided in § 146.135, except that the oranges may deviate from the standards for maturity in that they are below the minimum for Brix and Brix acid ratio for such oranges, and to which juice may be added not more than 10 percent by volume of the VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00613 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 604 21 CFR Ch. I (4–1–16 Edition) § 146.152 unfermented juice obtained from or anges of the species Citrus reticulata or Citrus reticulata hybrids (except that this limitation shall not apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) are removed, and pulp and or ange oil may be adjusted in accordance with good manufacturing practice. If pulp is added it shall be other than washed or spent pulp. The juice or por tions thereof may be so treated by heat as to reduce substantially the enzy matic activity and number of viable microorganisms, and it may be chilled or frozen, or it may be so treated by heat, either before or after sealing in containers, as to prevent spoilage. (b) The name of the food is ‘‘Orange juice for manufacturing’’. [42 FR 14433, Mar. 15, 1977, as amended at 57 FR 57667, Dec. 7, 1992] § 146.152 Orange juice with preserva tive. (a) Orange juice with preservative is the food prepared for further manufac turing use. It complies with the re quirements for composition of orange juice for manufacturing as provided for in § 146.151, except that a preservative is added to inhibit spoilage. It may be heat-treated to reduce substantially the enzymatic activity and the number of viable microorganisms. (b) The preservatives referred to in paragraph (a) of this section are any safe and suitable preservatives or com binations thereof. (c) The name of the food is ‘‘Orange juice with preservative’’. (d) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. In addition, the name of each preservative shall be proceeded by a statement of the percent by weight of the preservative used. If the food is packed in container sizes that are less than 19 liters (5 gallons), the label shall bear a statement indicating that the food is for further manufac turing use only. (e) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statement specified in paragraph (d) of this sec tion for naming the preservative ingre dient used shall immediately and con spicuously precede or follow the name of the food, without intervening writ ten, printed, or graphic matter. [42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22, 1979; 58 FR 2881, Jan. 6, 1993] § 146.153 Concentrated orange juice for manufacturing. (a) Concentrated orange juice for manufacturing is the food that com plies with the requirements of com position and label declaration of ingre dients prescribed for frozen con centrated orange juice by § 146.146, ex cept that it is either not frozen or is less concentrated, or both, and the or anges from which the juice is obtained may deviate from the standards for maturity in that they are below the minimum Brix and Brix-acid ratio for such oranges: Provided, however, that the concentration of orange juice solu ble solids is not less than 20° Brix. (b) The name of the food is ‘‘Con centrated orange juice for manufac turing, lll’’ or ‘‘lll orange juice concentrate for manufacturing’’, the blank being filled in with the figure showing the concentration of orange juice soluble solids in degrees Brix. [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2881, Jan. 6, 1993] § 146.154 Concentrated orange juice with preservative. (a) Concentrated orange juice with preservative complies with the require ments for composition and labeling of optional ingredients prescribed for con centrated orange juice for manufac turing by § 146.153, except that a pre servative is added to inhibit spoilage. (b) The preservatives referred to in paragraph (a) of this section are any safe and suitable preservatives or com binations thereof. (c) The name of the food is ‘‘Con centrated orange juice with preserva tive, lll’’, the blank being filled in with the figure showing the concentra tion of orange juice soluble solids in degrees Brix. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00614 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 605 Food and Drug Administration, HHS § 146.185 (d) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. In addition, the name of each preservative shall be preceded by a statement of the percent by weight of the preservative used. If the food is packed in container sizes that are less than 19 liters (5 gallons), the label shall bear a statement indicating that the food is for further manufac turing use only. (e) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the statement specified in paragraph (d) of this sec tion for naming the preservative ingre dient used shall immediately and con spicuously precede or follow the name of the food, without intervening writ ten, printed, or graphic matter. [42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22, 1979; 58 FR 2882, Jan. 6, 1993] § 146.185 Pineapple juice. (a) Identity. (1) Pineapple juice is the juice, intended for direct consumption, obtained by mechanical process from the flesh or parts thereof, with or with out core material, of sound, ripe pine apple (Ananas comosus L. Merrill). The juice may have been concentrated and later reconstituted with water suitable for the purpose of maintaining essen tial composition and quality factors of the juice. Pineapple juice may contain finely divided insoluble solids, but it does not contain pieces of shell, seeds, or other coarse or hard substances or excess pulp. It may be sweetened with any safe and suitable dry nutritive car bohydrate sweetener. However, if the pineapple juice is prepared from con centrate, such sweeteners, in liquid form, also may be used. It may contain added vitamin C in a quantity such that the total vitamin C in each 4 fluid ounces of the finished food amounts to not less than 30 milligrams and not more than 60 milligrams. In the proc essing of pineapple juice, dimethyl polysiloxane complying with the re quirements of § 173.340 of this chapter may be employed as a defoaming agent in an amount not greater than 10 parts per million by weight of the finished food. Such food is prepared by heat sterilization, refrigeration, or freezing. When sealed in a container to be held at ambient temperatures, it is so proc essed by heat, before or after sealing, as to prevent spoilage. (2) The name of the food is ‘‘Pine apple juice’’ if the juice from which it is prepared has not been concentrated and/or diluted with water. The name of the food is ‘‘Pineapple juice from con centrate’’ if the finished juice has been made from pineapple juice concentrate as specified in paragraph (a) of this sec tion. If a nutritive sweetener is added, the label shall bear the statement ‘‘Sweetener added.’’ If no sweetener is added, the word ‘‘Unsweetened’’ may immediately precede or follow the words ‘‘Pineapple juice’’ or ‘‘Pineapple juice from concentrate.’’ (3) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. (b) Quality. (1) The standard of qual ity for pineapple juice is as follows: (i) The soluble solids content of pine apple juice (exclusive of added sugars) without added water shall not be less than 10.5° Brix as determined by refrac tometer at 20 °C uncorrected for acid ity and read as degrees Brix on Inter national Sucrose Scales. Where the juice has been obtained using con centrated juice with addition of water, the soluble pineapple juice solids con tent (exclusive of added sugars) shall be not less than 12.8° Brix, uncorrected for acidity and read as degrees Brix on the International Sucrose Scales. (ii) The acidity, as determined by the method prescribed in paragraph (b)(2)(ii) of this section, is not more than 1.35 grams of anhydrous citric acid per 100 milliliters of the juice. (iii) The ratio of the degrees Brix to total acidity, as determined by the method prescribed in paragraph (b)(2)(iii) of this section, is not less than 12. (iv) The quantity of finely divided ‘‘insoluble solids’’, as determined by the method prescribed in paragraph (b)(2)(iv) of this section, is not less than 5 percent nor more than 30 per cent. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00615 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 606 21 CFR Ch. I (4–1–16 Edition) § 146.187 (2) The methods referred to in para graph (b)(1) of this section are as fol lows: (i) Determine the degrees Brix of the pineapple juice by the method pre scribed in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists,’’ 13th Ed. (1980), sec tion 31.009, ‘‘Solids by Means of Spin dle—Official Final Action,’’ which is incorporated by reference. Copies may be obtained from the AOAC INTER NATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Ar chives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (ii) Determine the total acidity of the pineapple juice by titration by the method prescribed in § 145.180(b)(2)(ix) of this chapter. (iii) Divide the degrees Brix deter mined as prescribed in paragraph (b)(2)(i) of this section by the grams of anhydrous citric acid per 100 milliliters of juice, determined as prescribed in paragraph (b)(2)(ii) of this section, and report the results as ratio of degrees Brix to total acidity. (iv) Determine the quantity of ‘‘in soluble solids’’ in pineapple juice as follows: Measure 50 milliliters of thor oughly stirred pineapple juice into a cone-shaped graduated tube of the long-cone type, measuring approxi mately 43⁄16 inches from tip to top cali bration and having a capacity of 50 milliliters. Place the tube in a suitable centrifuge the approximate speed of which is related to diameter of swing in accordance with the table imme diately below. The word ‘‘diameter’’ means the over-all distance between the tips of opposing centrifuge tubes in operating position. Diameter (inches) Approxi mate revo lutions per minute 10 ......................................................................... 1,609 101⁄2 ..................................................................... 1,570 11 ......................................................................... 1,534 111⁄2 ..................................................................... 1,500 12 ......................................................................... 1,468 121⁄2 ..................................................................... 1,438 13 ......................................................................... 1,410 Diameter (inches) Approxi mate revo lutions per minute 131⁄2 ..................................................................... 1,384 14 ......................................................................... 1,359 141⁄2 ..................................................................... 1,336 15 ......................................................................... 1,313 151⁄2 ..................................................................... 1,292 16 ......................................................................... 1,271 161⁄2 ..................................................................... 1,252 17 ......................................................................... 1,234 171⁄2 ..................................................................... 1,216 18 ......................................................................... 1,199 181⁄2 ..................................................................... 1,182 19 ......................................................................... 1,167 191⁄2 ..................................................................... 1,152 20 ......................................................................... 1,137 The milliliter reading at the top of the layer of ‘‘insoluble solids,’’ after centrifuging 3 minutes, is multiplied by two to obtain the percentage of ‘‘insoluble solids.’’ (3) If the quality of pineapple juice falls below the standard prescribed in paragraph (b)(1) of this section, the label shall bear the general statement of substandard quality specified in § 130.14 (a) of this chapter, in the man ner and form therein specified. (c) Fill of container. (1) The standard of fill of container for pineapple juice, except when the food is frozen, is not less than 90 percent of the total capac ity of the container, as determined by the general method for fill of container prescribed in § 130.12(b) of this chapter. (2) If pineapple juice falls below the standard of fill of container prescribed in paragraph (c)(1) of this section, the label shall bear the statement of sub standard fill specified in § 130.14(b) of this chapter, in the manner and form therein specified. [42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19, 1982; 47 FR 52694, Nov. 23, 1982; 49 FR 10101, Mar. 19, 1984; 50 FR 19524, May 9, 1985; 54 FR 24895, June 12, 1989; 58 FR 2882, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 146.187 Canned prune juice. (a) Canned prune juice is the food prepared from a water extract of dried prunes and contains not less than 18.5 percent by weight of water-soluble sol ids extracted from dried prunes. The quantity of prune solids may be ad justed by the concentration, dilution, or both, of the water extract or ex tracts made. Such food may contain one or more of the optional acidifying VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00616 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 607 Food and Drug Administration, HHS Pt. 150 ingredients specified in paragraph (b)(1) of this section, in a quantity suf ficient to render the food slightly tart; it may contain honey added within the quantitative limits prescribed by para graph (b)(2) of this section; and it may contain added vitamin C in a quantity prescribed by paragraph (b)(3) of this section. Such food is sealed in a con tainer and so processed by heat, before or after sealing, as to prevent spoilage. (b) The optional ingredients referred to in paragraph (a) of this section are: (1) One or any combination of two or more of the following acidifying ingre dients: (i) Lemon juice. (ii) Lime juice. (iii) Citric acid. (2) Honey, in a quantity not less than 2 percent and not more than 3 percent by weight of the finished food. (3) Vitamin C, in a quantity such that the total vitamin C in each 6 fluid ounces of the finished food amounts to not less than 30 milligrams and not more than 50 milligrams. (c)(1) The name of the food is ‘‘Prune juice—a water extract of dried prunes’’. For the purposes of the Federal Food, Drug, and Cosmetic Act concerning the label declaration of the name of the food, the explanatory statement ‘‘A water extract of dried prunes’’ may ap pear immediately below the words ‘‘prune juice’’, but there shall be no in tervening written, printed, or graphic matter, and the type used for the words ‘‘A water extract of dried prunes’’ shall be of the same style and not less than half the print size of the type used for the words ‘‘prune juice’’. (2)(i) When one or more of the acidifying ingredients specified in paragraph (b)(1) of this section are used, the label shall bear the statement ‘‘lll added’’ or ‘‘with added lll’’, the blank being filled in with the name or names of the optional ingredients used. (ii) When honey, as specified in para graph (b)(2) of this section, is used the label shall bear the statement ‘‘with lll honey’’ or ‘‘lll honey added’’, the blank to be filled in with the per cent by weight of the honey in the fin ished food or with the statement ‘‘be tween 2 and 3%’’. (iii) When one or more of the ingredi ents designated in paragraph (b)(1) of this section and the ingredient des ignated in paragraph (b)(2) of this sec tion are used, the statements specified in paragraphs (c)(2) (i) and (ii) of this section may be combined, as for exam ple, ‘‘with lemon juice and between 2 and 3% honey added’’. (iv) When vitamin C is added as pro vided in paragraph (b)(3) of this sec tion, it shall be designated on the label as ‘‘vitamin C added’’ or ‘‘with added vitamin C’’. (3) Wherever the name of the food ap pears on the label so conspicuously as to be easily seen under customary con ditions of purchase, the words specified in this paragraph, showing the optional ingredients used, shall immediately and conspicuously precede or follow such name, without intervening writ ten, printed, or graphic matter. (d) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14433, Mar. 15, 1977, as amended at 58 FR 2882, Jan. 6, 1993] PART 150—FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PROD UCTS Subpart A [Reserved] Subpart B—Requirements for Specific Standardized Fruit Butters, Jellies, Pre serves, and Related Products Sec. 150.110 Fruit butter. 150.140 Fruit jelly. 150.160 Fruit preserves and jams. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14445, Mar. 15, 1977, unless otherwise noted. 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